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Active NON-SBIR/STTR RPGS NIH (US)

Identifying Multi-Level Predictors and Outcomes of Oral Anticancer Medication Adherence Initiation and Persistence among Patients with Hematologic Malignancies

$6.57M USD

Funder NATIONAL CANCER INSTITUTE
Recipient Organization University of Pittsburgh At Pittsburgh
Country United States
Start Date Aug 01, 2024
End Date Jul 31, 2029
Duration 1,825 days
Number of Grantees 1
Roles Principal Investigator
Data Source NIH (US)
Grant ID 10942408
Grant Description

Oral anticancer medications (OAM) are becoming standard of care for growing numbers of patients. Multiple myeloma (MM), chronic myeloid leukemia (CML), and chronic lymphocytic leukemia (CLL) are hematologic malignancies for which costly, long-term OAMs are a life-extending therapy. However, OAM nonadherence

(i.e., delaying, not starting, taking more/less than prescribed, or stopping use) is a critical understudied issue that can dramatically affect cancer outcomes. The reasons for poor adherence, the characteristics of those at risk for poor adherence, and the effects of poor adherence on health outcomes are poorly understood,

particularly in those with hematologic malignancies. Multi-level factors that affect adherence may be unique based on adherence phase, including initiation (time from prescription to first dose taken) and persistence (consistently taking as prescribed). Our preliminary data among patients with MM identified 3 distinct OAM

adherence trajectory groups. While almost 63% of patients maintained near-perfect adherence over 6 months, over 27% began at 85% and dropped below 70%, and 10% had consistently very low adherence (40%). Self- reported race and ethnicity (non-Hispanic Black/African American and Hispanic vs. non-Hispanic white)

predicted very low adherence, which was associated with reduced quality of life (QOL). System barriers (i.e., care delays, specialty pharmacy barriers, insurance approvals, high costs) and symptom concerns influenced adherence and negatively affected QOL and employment decisions. Our long-term goal is to develop targeted,

culturally sensitive interventions to improve OAM adherence and health outcomes, particularly among groups most at risk for disparate cancer outcomes. The overall objective of this theoretically guided study is to comprehensively characterize OAM adherence initiation and persistence and identify temporal correlates with

1) multi-level factors that increase risk for poor adherence and 2) health outcomes in socioeconomically diverse patients with MM, CML, and CLL. A prospective (pre-therapy [T0] with repeated monthly measures [T1-T12] for one-year post-therapy initiation), mixed methods design will be used in 306 socioeconomically

diverse patients prescribed long-term OAM therapy for MM, CML, and CLL. Aim 1 is to characterize the initiation and persistence phases of OAM adherence. Aim 2 will identify multi-level factors influencing OAM adherence initiation and persistence. Aim 3 will explore relationships between OAM adherence initiation and

persistence and health outcomes (health care utilization, QOL, molecular response, progression-free survival, overall survival). Aim 4 will explore factors affecting the patient experience of taking OAMs at initiation and during persistence, based on semi-structured interviews in a sample subset with differing levels of adherence.

This study will fill critical gaps needed to identify those at risk of nonadherence for targeted support and inform future clinically relevant interventions to improve OAM adherence, contribute to equitable health outcomes, and inform adherence research for other cancer types.

All Grantees

University of Pittsburgh At Pittsburgh

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